[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614838":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":32,"responsibleParty":45,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Xencor, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","XmAb657 administered SC",[13],"Biological: XmAb657",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","XmAb657","Biological",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Mark Osterman, MD, MSCE","STUDY_DIRECTOR",[26,30],{"name":27,"role":28,"phone":20,"phoneExt":20,"email":29},"Noriko Iikuni, MD, PhD","CONTACT","657-aiinfo@xencor.com",{"name":31,"role":28,"phone":20,"phoneExt":20,"email":29},"Jaime Mertz",[33],{"facility":34,"status":35,"city":36,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":20},"Xencor Investigative Site","RECRUITING","Melbourne","Australia","AU",{"type":40,"coordinates":41},"Point",[42,43],144.96332,-37.814,{"lat":43,"lon":42},{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100614838","phase-1-a-phase-1-open-label-study-to-evaluate-safety-in-healthy-participants-and-participants-with-autoimmune-diseases-100614838",false,"NCT07284797","A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases","A Phase 1, First-in-Human, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of XmAb657 in Healthy Participants and in Participants With Autoimmune Diseases","Inclusion Criteria:\n\nHealthy participants - Adult participants in good health\n\nIdiopathic inflammatory myopathy (IIM) participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)\u002FAmerican College of Rheumatology (ACR) Classification Criterion for IIM\n\nSystemic sclerosis (SSc) participants - Adult participants that meet the 2013 ACR\u002FEULAR Classification Criteria for SSc\n\nSjogren's Disease participants that meet the 2016 ACR\u002FEULAR Classification Criteria for Primary Sjogren's Syndrome\n\nAll participants - Use of highly effective methods of contraception\n\nExclusion Criteria:\n\n* Major surgery within 12 weeks prior to dosing or planned within the study\n* Recurrent infections or active clinically significant infection\n* Active or untreated latent tuberculosis\n* Cancer or history of cancer or lymphoproliferative disease within the previous 5 years\n* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease\n\nNote: Additional, more specific inclusion\u002Fexclusion criteria are defined in the protocol.",true,"ALL","18 Years","75 Years",{"count":59,"type":60},60,"ESTIMATED","INTERVENTIONAL",[63],"PHASE1","The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.",[66,67,68,69],"Healthy","Idiopathic Inflammatory Myopathies","Systemic Sclerosis","Sjögren's Disease",[71,72,73,74,75,76,77],"Myopathy","Myositis","Scleroderma","Autoimmune Diseases","IIM","SjD","SSc","2026-05-20",{"date":80,"type":81},"2026-05-22","ACTUAL",{"date":83,"type":81},"2026-02-24",{"date":85,"type":60},"2028-10",{"name":5,"class":6},1]